Study of Catheter Based Renal Denervation Therapy in Hypertension

DENERVATION OF RENAL SYMPATHETIC ACTIVITY AND HYPERTENSION STUDY

The DEPART study end points are to provide conclusive evidence, using a randomized, double blinded, sham procedure controlled study design, that radiofrequency renal denervation:

1. reduces daytime ambulatory blood pressure,
2. improves nocturnal dipping in blood pressure at the ambulatory blood pressure recording.

Inclusion Criteria:

• They have a mandatory > 3 antihypertensive medication therapy, including a thiazide or a loop diuretic (according to the patient's renal function, unless documented side-effects) and at least one attempt to treat with spironolactone, given at usual recommended dose since at least 8 weeks, before inclusion,
• A mandatory check list of secondary cause of hypertension has been excluded
• They succeed the pill count test.
• They have a mandatory ambulatory blood pressure monitoring before inclusion with at least 70% of valid readings during daytime (08:00 am 08:00 pm, using a sampling frequency of 20 minutes, only devices validated according to http://www.dableducational.org are permitted), where daytime ambulatory blood pressure of systolic and/or diastolic blood pressure exceeds 135 mmHg and/or 85 mmHg, respectively. Daytime ambulatory blood pressure of systolic and/or diastolic blood pressure below 135 mmHg and/or 85 mmHg, respectively, is acceptable for inclusion in the study if the patient takes four or more antihypertensive medication (3).

Exclusion Criteria:

• Patients with an eGFR <30ml/min/m² are excluded,
• patients with known renal atherosclerotic lesions,
• previous procedures in the renal arteries,
• known unsuitable anatomy for the procedure,
• previous nephrectomy,
• contrast agent allergy,
• hyperthyroidia.